FDA Approves Darzalex Providing a New Treatment for Patients with Multiple Myeloma

Posted on November 17th, 2015 by

Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma.

Darzalex is the first monoclonal antibody approved for treating multiple myeloma. Darzalex appears to be effective in patients with multiple myeloma that has stopped responding to standard therapies according to study results recently published in the New England Journal of Medicine.

Multiple myeloma is a cancer of plasma cells, which are a special type of white blood cell that are part of the body’s immune system. In the U.S., approximately 70,000 people are living with multiple myeloma and approximately 24,000 new individuals are diagnosed annually. Patients with multiple myeloma have increased numbers of abnormal plasma cells that may produce increased quantities of dysfunctional antibodies detectable in the blood and/or urine. Patients with multiple myeloma who have become refractory—or resistant—to the drugs Revlimid® (lenalidomide) and Velcade® (bortezomib) have limited treatment options. There is no standard treatment for these patients and they typically have a poor prognosis.

Understanding Multiple Myeloma

There are several treatment options for multiple myeloma; however, once the cancer stops responding to standard therapies, it is referred to as refractory and therapeutic options at that point in the disease remain scarce.

Darzalex injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.  Multiple myeloma cells overexpress the protein called CD38. Therefore, researchers designed Darzalex to specifically target and bind to CD38. Darzalex binds to the cancer cells, and through multiple pathways, the cancer cells are killed once the binding occurs.

The recent trial evaluating daratumumab included patients with multiple myeloma that had stopped responding to a median of 4 prior therapies. This was an early-phase trial evaluating daratumumab, so patients were treated with 2 different doses of the agent. Among patients treated at the higher dose, 36% achieved a disease response. Among responders, 65% of patients did not experience disease progression at one year following therapy. Daratumumab was well tolerated, particularly considering this group of patients had received extensive prior therapy.

Reference: Lokhohrst H, Plesner T, Laubach J, et al. Targeting CD38 with daratumumab monotherapy in multiple myeloma. New England Journal of Medicine. 2015; August 26, 2015DOI: 10.1056/NEJMoa1506348.

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Tags: Darzlex, monoclonal antibody, Multiple Myeloma, News, Recurrent Multiple Myeloma

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